All Human Subjects Research Applications Must be Submitted Through iStar
Investigators must submit IRB applications through the online iStar system. Subsequent reviews, amendments, and reportable event must also be submitted through iStar. An iStar account is needed to utilize this system. iStar Resources/Training are available here.

Obtaining an iStar Account
To obtain an iStar account, follow these 3 steps:

1. Type “iStar Account Request” in the subject line of an email.
2. Include in the body of the email your name, your campus (UPC or HSC), school / department, and email address.
3. Send the email to istar@usc.edu

If you are having trouble obtaining an iStar account, or need technical help with the system please call (323) 276-2238 or email istar@usc.edu

CITI (Human Subjects Education)
CITI is the online education program required of all USC investigators and key personnel conducting human subjects research. IRB applications are not approved until this education requirement is met. Information on CITI is available here.

Submitting a New Full Board or Expedited Application
Full Board and Expedited studies use the same application template and are submitted in the following manner:

1. Sign in to iStar
2. Click on the "New Study" button in the left column
3. Fill out the application completely.
4. Click "Submit Application to IRB" under "My Activities" on the left toolbar.

Tips for New Applications: Model IRB Application | Expedited Categories | IRB Reviewer Guidelines

Submitting a Claim of Exemption
Exempt studies also require IRB review and approval but use a different application template than the one used above.

1. Sign in to iStar
2. Click "New Study"
3. In question 4.1 make sure to select "Claim of Exemption"
4. Fill out the application completely
5. Click "Submit Application to IRB" under "My Activities" on the left toolbar.

Tips for Claim of Exemptions: Model Exemption Application | Exemption Categories

Submiting an Amendment to a Previously Approved Protocol
Any proposed changes to a project must be reviewed and approved by the IRB before the change can be implemented. To submit an amendment / revision to a currently approved project:

1. Sign in to iStar
2. Click the study title
3. Click the “New Amendment” tab in the study workspace
4. Answer the questions in the amendment application
5. Complete the amendment application
   
6. Click "Submit Amendment to IRB" button

Tips for Amendments: iStar amendment quick sheet

Submitting a Continuing Review
Full Board and Expedited review study approvals are valid for no more than 365 days. If study activities are to continue beyond the expiration date, it is necessary to to submit a continuing review application.

1. Sign in to iStar
2. Click the study title
3. Click the “New Continuing Review” button
4. Fill out the application
5. Click "Submit Continuing Review to IRB" under "My Activities" on the left toolbar.

Tips for Continuing Reviews: User guide for Investigators and Study Personnel | IRB Requirements for Continuing Review After Enrollment and Data Collection are Completed | IRB Continuing Review for Full Board Studies | IRB Reviewer Guidelines

Submitting a Reportable Event to a Previously Approved Protocol
Any Reportable Events (internal or external adverse events, DSM reports, protocol deviations/errors) must be submitted via iStar.

1. Sign in to iStar
2. Click the study title
3. Click on “New Reportable Event” in the study workspace to submit the reportable events.
4. Answer the questions in the Reportable Event Smart Form. The Smart Form will guide you through the necessary questions for you to complete the report.
5. If you need some guidance as to how to answer Smart Form questions, click on “Guidance” on the right hand side of the screen.